510(k) K242091
- Device
- Bolo Button System
- Applicant
- Fusion Orthopedics
- 510(k) number
- K242091
- Product code
- HTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-12-23
- Date received
- 2024-07-17
- Regulation
- 888.3030
- Classification name
- Washer, Bolt Nut
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Catalina Pardo
- Address
- 6859 E Rembrandt Ave. Suite 122 Mesa AZ US 85212 85212
FDA Registration Numbers
- 1423662
- 1450662
- 1833506
- 3026586698
- 3014967969
- 3005180920
- 3006498370
- 9680619
- 3021226419
- 3009540749
- 1649390
- 3013176080
- 3032412536
- 3002807315
- 3021008900
- 3009973699
- 3010386387
- 1043534
- 3006801265
- 3010120339
- 3016727307
- 3010060157
- 3004464325
- 1835831
- 3001239363
- 3015453963
- 2183744
- 3004579081
- 8044102
- 3009158523
- 2183946
- 2031009
- 3023852420
- 3013756169
- 2032098
- 3003541440
- 1018470
- 3005290844
- 3014522470
- 1833824
- 3010197224
- 3007420745
- 3015806723
- 3002579136
- 3025603301
- 2032521
- 3012818475
- 2031093
- 3034676720
- 3004142400
- 1643264
- 3006946279
- 1043653
- 1526439
- 2246552
- 2648920
- 3014763043
- 2027754
- 3015882686
- 3007289093
- 1721676
- 3014129047
- 3015718210
- 2532027
- 3006460162
- 3007593722
- 3027339877
- 3004635447
- 3002949614
- 1064858
- 3011580264
- 9612277
- 3017196117
- 3043620689
- 3013767421
- 1222274
- 3010237768
- 3007923096
- 8010177
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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